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Spots Global Cancer Trial Database for Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer

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Trial Identification

Brief Title: Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer

Official Title: Phase I / Randomized Phase II Study of Second Line Therapy With Irinotecan and Cetuximab With or Without RAD001, an Oral mTOR Inhibitor for Patients With Metastatic Colorectal Cancer: Hoosier Oncology Group GI05-102

Study ID: NCT00522665

Study Description

Brief Summary: The addition of RAD001, an mTOR inhibitor, to irinotecan and anti-EGFR antibody cetuximab may increase efficacy for patients with metastatic colorectal cancer who progressed on prior chemotherapy. This approach is biologically directed to overall target the cancer cell at multiple levels, and potentially preventing chemotherapy and EGFR-therapy resistance.

Detailed Description: OUTLINE: This is a multi-center study. PHASE I: * UGT1A1 \*28 7/7 genotype IS NOT present * Cetuximab 250 mg/m2 IV days 1, 8, and 15 * Irinotecan 125 mg/m2 IV days 1 and 8 * RAD001 PO QD (dose determined at the time of registration; subjects will remain at this dose level until treatment discontinuation) PHASE II: * Randomization based on UGT1A1 \*28 7/7 Genotype or Prior Irinotecan Exposure ARM A: * Cetuximab 250 mg/m2 IV days 1, 8, and 15 * Irinotecan 125 mg/m2 IV days 1 and 8 AT TIME OF PROGRESSIVE DISEASE, ARM A TREATMENT WILL CROSSOVER: * Cetuximab 250 mg/m2 IV days 1, 8, and 15 * Irinotecan 125 mg/m2 IV days 1 and 8 * RAD001 PO QD (maximum tolerated dose) ARM B: * Cetuximab 250 mg/m2 IV days 1, 8, and 15 * Irinotecan 125 mg/m2 IV days 1 and 8 * RAD001 PO QD (maximum tolerated dose) AT TIME OF PROGRESSIVE DISEASE, ARM B TREATMENT WILL BE DISCONTINUED ECOG performance status 0-2 Life Expectancy: Not specified Hematopoietic: * Absolute neutrophil count (ANC) ≥ 1,500 mm3 * Platelets ≥ 100,000 mm3 * Hemoglobin (Hgb) ≥ 9 g/dL * White blood cell count (WBC) ≥ 2,000 mm3 * INR \< 1.5 x upper limit of normal (ULN) if not on anticoagulation (if on anticoagulation must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin) * PTT \< 1.5 x ULN Hepatic: * Bilirubin ≤ 1.5 x ULN * Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN * Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x ULN * Albumin ≥ 3.0 g/dL Renal: * Calculated creatinine clearance of ≥ 60 cc/min using the Cockcroft-Gault formula Cardiovascular: * No uncontrolled cardiac arrhythmia requiring medication, transient ischemic attack (TIA), or cerebrovascular accident (CVA) within 6 months prior to being registered for protocol therapy * No uncontrolled congestive heart failure, myocardial infarction, or unstable angina within 6 months prior to being registered for protocol therapy Pulmonary: * No severely impaired lung function as demonstrated by pulse O2 saturation ≤ 90% at rest on room air, or pulmonary function test FEV1 ≤ 2L * No history of prior chronic lung infection such as tuberculosis, atypical tuberculosis, or histoplasmosis as evidenced by a chest CT or x-ray within 21 days prior to being registered for protocol therapy

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

Medical & Surgical Specialists, LLC, Galesburg, Illinois, United States

Cancer Care Center of Southern Indiana, Bloomington, Indiana, United States

Oncology Hematology Associates of SW Indiana, Evansville, Indiana, United States

IN Onc/Hem Associates, Indianapolis, Indiana, United States

Indiana University Simon Cancer Center, Indianapolis, Indiana, United States

St. Vincent Hospital & Health Centers, Indianapolis, Indiana, United States

Community Regional Cancer Center, Indianapolis, Indiana, United States

Arnett Cancer Care, Lafayette, Indiana, United States

Horizon Oncology Center, Lafayette, Indiana, United States

Monroe Medical Associates, Munster, Indiana, United States

Center for Cancer Care, Inc., P.C., New Albany, Indiana, United States

Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States

Siteman Cancer Center, St. Louis, Missouri, United States

Contact Details

Name: Gabriela Chiorean, M.D.

Affiliation: Hoosier Oncology Group, Inc.

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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